510(k) · Cleared
ClearedHEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Feb 1, 2021 as substantially equivalent to K183279 (Medos International SARL, 2019) and 1 other predicate after a 35-day review. Its family tree reaches back 14 generations to 1997.
- Decided
- Feb 1, 2021
- Review
- 35 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K971358 (1997). 46 ancestors in all, the oldest K930893 (1993). No later device cites it as a predicate yet.
- Root · 14 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 10 generations between
- 3 generations backK173859 HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL · 2018
- 2 generations backK183506 HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL · 2019
- 1 generation backK200949 HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL · 2020
- This deviceK203794 HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL · 2021
Show all 14 generations
- Root · 14 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 13 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 12 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 11 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 10 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 9 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 8 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- 7 generations backK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
- 6 generations backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
- 5 generations backK120078 Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company · 2012
- 4 generations backK133794 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord…Depuy Mitek, A Johnson & Johnson Company · 2014
- 3 generations backK173859 HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL · 2018
- 2 generations backK183506 HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL · 2019
- 1 generation backK200949 HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL · 2020
- This deviceK203794 HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −13 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −12 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −11 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −10 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −9 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −8 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| −7 | K090124 | Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model… | Depuy Mitek, A Johnson & Johnson Company | 2009 | 2 |
| −6 | K100012 | Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| −5 | K120078 | Healix Advance BR Anchor | Depuy Mitek Inc., Johnson and Johnson Company | 2012 | — |
| −4 | K133794 | 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture… | Depuy Mitek, A Johnson & Johnson Company | 2014 | — |
| −3 | K173859 | HEALIX ADVANCE Anchor with DYNACORD Suture | Medos International SARL | 2018 | — |
| −2 | K183506 | HEALIX ADVANCE Anchor with DYNACORD Suture | Medos International SARL | 2019 | — |
| −1 | K200949 | HEALIX ADVANCE Anchor with DYNATAPE Suture | Medos International SARL | 2020 | — |
| 0 (this device) | K203794 | HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture | Medos International SARL | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K183279 | HEALIX Ti ANCHOR with DYNACORDSummary page 5…The HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Equivalence Suture is substantially equivalent to the predicates: • K183279, HEALIX Ti™ ANCHORS with DYNACORD™ Suture (Primary Predicate) • K200949… | 2019 |
| * | K200949 | HEALIX ADVANCE Anchor with DYNATAPE SutureSummary page 5…redicates: • K183279, HEALIX Ti™ ANCHORS with DYNACORD™ Suture (Primary Predicate) • K200949, HEALIX ADVANCE™ Anchor with DYNATAPE™ Suture (Reference Predicate) Device HEAL… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 13 of the 46 ancestors have a recall of any class.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The HEALIX Ti™ Dual Threaded Suture Anchor is intended for soft-tissue-to-bone fixation in association with postoperative immobilization. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral…
Read the full statement (82 words)
The HEALIX Ti™ Dual Threaded Suture Anchor is intended for soft-tissue-to-bone fixation in association with
postoperative immobilization.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular Separation
Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair,
Iliotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203794: HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203794
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026